Laser Ablation for Prostate Cancer

(TPF-LITT Trial)

Overseen By Luanda Perez, PA.C

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Urological Research Network, LLC

Disqualifiers: Neurological conditions, Neurogenic bladder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 1 day

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new laser treatment for men aged 50-80 with certain types of prostate cancer. The laser heats and destroys cancer cells, guided by advanced imaging to protect healthy tissue. The goal is to reduce side effects like impotence and incontinence seen with traditional treatments. Recently, there has been an increase in research and development of targeted prostate cancer treatments due to the high number of localized prostate cancers.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of this treatment for prostate cancer?

Research shows that focal laser ablation (FLA) is an emerging treatment for prostate cancer that aims to effectively target the disease while minimizing side effects compared to more invasive treatments. Additionally, studies indicate that transperineal laser ablation (TPLA) is technically feasible, safe, and effective as a treatment for prostate cancer that has not responded to other therapies. ^{1 2 3 4 5}

Is laser ablation for prostate cancer safe?

Laser ablation for prostate cancer, including methods like transperineal focal laser ablation (TPLA) and focal laser ablation (FLA), is considered to have a low risk of side effects compared to more invasive treatments. Studies suggest it is generally safe, with a focus on reducing side effects while effectively treating the cancer. ^{1 2 3 6 7}

How is the TRANBERG® Transperineal Fusion Laser--Induced Thermal Therapy (TPF-LITT) treatment for prostate cancer different from other treatments?

The TRANBERG® Transperineal Fusion Laser--Induced Thermal Therapy (TPF-LITT) is unique because it is a minimally invasive treatment that uses laser energy to precisely target and destroy cancerous tissue in the prostate, aiming to reduce side effects compared to traditional whole-gland treatments. It is an investigational therapy that focuses on treating only the affected area, potentially preserving more of the prostate's normal function. ^{1 2 4 5 8}

Research Team

FERNANDO J BIANCO, MD

Principal Investigator

Urological Research Network

Isabel H Lopez, BS., MBA

Principal Investigator

Urological Research Network

Eligibility Criteria

Men aged 50-80 with low to intermediate risk prostate cancer, who can consent and follow the study plan. They should have a prostate size of 18-100 cc by ultrasound or MRI, PSA <20 ng/ml, no urinary retention, creatinine levels <2 ng/dl with GFR >45. Excluded are those with neurogenic bladder issues, poor sexual function scores (SHIM score <14), surgery risks like infection or coagulopathy, high post-void residual urine volume (>250 mL), prior prostate cancer treatments or major neurological conditions.

Inclusion Criteria

I am willing and able to follow all study procedures and attend all visits.

Willing and able to sign informed consent

My prostate size is between 18 and 100 cc according to an MRI.

Exclusion Criteria

I do not have major neurological conditions like Alzheimer's or Parkinson's.

I cannot have local anesthesia due to health reasons.

I cannot have TPFLA surgery due to a health condition like an infection or heart risk.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo TRANBERG® TPF-LITT procedure for prostate cancer ablation under local anesthesia

1 day

1 visit (in-person)

Immediate Post-Treatment Monitoring

Multiparametric MRI conducted immediately after the procedure to assess ablation area

24-72 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including MRI and PROMs assessments

12 months

Multiple visits at 1, 3, 6, 9, and 12 months

Treatment Details

Interventions

• TRANBERG® Transperineal Fusion Laser--Induced Thermal Therapy of Prostate Cancer (TPF-LITT)

Trial Overview The trial tests TRANBERG® TPF-LITT for treating prostate tumors in an office setting under local anesthesia. It aims to preserve organ function while targeting tumor ablation using fusion imaging guidance. The study will evaluate safety and tolerance of this minimally invasive procedure and its effects on urinary and sexual functions as well as MRI changes in the treated area over time.

Participant Groups

Group I: TPF-LITT ARM Experimental Treatment 1 Intervention

partial gland ablation of the prostate using laser device and imaging fusion

TRANBERG® Transperineal Fusion Laser--Induced Thermal Therapy of Prostate Cancer (TPF-LITT) is already approved in United States, European Union for the following indications:

Approved in United States as TRANBERG Thermal Therapy System for:

• Soft tissue ablation, such as prostate tumors

Approved in European Union as TRANBERG Thermal Therapy System for:

• Not specified in provided sources, but generally used for soft tissue ablation including prostate tumors

Who Is Running the Clinical Trial?

Urological Research Network, LLC

Lead Sponsor

Trials

5

Recruited

10,200+

Findings from Research

Transperineal focal laser ablation (TPLA) for prostate cancer was performed successfully in 12 patients with no serious adverse events, indicating its safety as a minimally invasive treatment option.

Imaging techniques like contrast-enhanced ultrasound (CEUS) and MRI effectively visualized the ablation zone, showing a high correlation with histopathological results, confirming no remaining cancer in the treated areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reliable Visualization of the Treatment Effect of Transperineal Focal Laser Ablation in Prostate Cancer Patients by Magnetic Resonance Imaging and Contrast-enhanced Ultrasound Imaging. van Riel, LAMJG., van Kollenburg, RAA., Freund, JE., et al.[2023]

Focal laser ablation (FLA) is a promising treatment for low-risk prostate cancer that effectively targets cancerous areas while minimizing damage to surrounding tissues, leading to fewer side effects compared to traditional therapies.

Current phase I clinical trials indicate that FLA provides accurate and reproducible ablation zones, and its effectiveness is being further evaluated in ongoing phase II trials, highlighting its potential as a well-tolerated treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laser ablation as focal therapy for prostate cancer. Wenger, H., Yousuf, A., Oto, A., et al.[2021]

Transperineal laser ablation (TPLA) guided by ultrasound/MR fusion is a safe and effective salvage treatment for patients with refractory focal prostate cancer, as shown in a study of five patients with no recurrence detected over an 18-month follow-up period.

The procedure resulted in a significant reduction in prostate-specific antigen (PSA) levels by over 70%, while preserving quality of life and functional outcomes, indicating its potential as a viable option for managing local recurrences after radiation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transperineal laser ablation (TPLA) with ultrasound/MRI fusion guidance in the treatment of localized radiotherapy-resistant prostate cancer. Manenti, G., Nezzo, M., Ryan, CP., et al.[2023]

Laser treatment combined with transurethral resection of the prostate shows promise for treating early-stage prostate cancer (T0, T1, and T2) with minimal complications.

In a follow-up study of 26 patients over 6 to 42 months, there have been no recorded local recurrences, suggesting the treatment's efficacy in preventing cancer return.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laser combined with TURP in the treatment of localized prostatic cancer. Samdal, F., Brevik, B.[2019]

Laser interstitial thermotherapy (LITT) using a 980-nm diode laser effectively induced necrosis in prostate cancer tumors in a rat model, with significant increases in necrosis volume observed at 1 hour and 48 hours post-treatment.

The study demonstrated a strong correlation between MRI-detected necrosis volumes and histological findings, suggesting that LITT is a reproducible and potentially effective minimally invasive treatment for prostate cancer that warrants further investigation in human subjects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Focal laser interstitial thermotherapy (LITT) at 980 nm for prostate cancer: treatment feasibility in Dunning R3327-AT2 rat prostate tumour. Colin, P., Nevoux, P., Marqa, M., et al.[2012]

Focal therapy (FT) for prostate cancer shows low side effects across various treatment modalities, with urinary continence rates between 90-100% and erectile dysfunction rates ranging from 5 to 52%.

Expert consensus indicates that different FT techniques may be more effective depending on tumor characteristics: HIFU is preferred for posterior lesions, cryotherapy for anterior tumors, and focal brachytherapy (FBT) for apical lesions, highlighting the need for personalized treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Which technology to select for primary focal treatment of prostate cancer?-European Section of Urotechnology (ESUT) position statement. Ganzer, R., Arthanareeswaran, VKA., Ahmed, HU., et al.[2018]

Focal therapy (FT) for localized prostate cancer shows excellent safety and functional outcomes, with post-operative pad-free rates ranging from 92.3% to 100% across various modalities, based on a review of 107 studies involving 6933 patients.

There is significant variability in erectile function outcomes after FT, with rates ranging from 0% to 94.4% for different treatments, highlighting the need for standardized assessment tools and high-quality comparative studies to better understand these therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional outcomes and safety of focal therapy for prostate cancer: a systematic review on results and patient-reported outcome measures (PROMs). Nicoletti, R., Alberti, A., Castellani, D., et al.[2023]

Focal laser ablation is a safe and feasible treatment for intermediate risk prostate cancer, with no serious adverse events reported in a trial involving 8 men over 6 months.

While the treatment successfully reduced prostate-specific antigen levels in 7 out of 8 participants, follow-up biopsies indicated that larger treatment margins may be necessary for complete tumor ablation, as cancer was still detected outside the treated area in some cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Focal Laser Ablation of Prostate Cancer: Phase I Clinical Trial. Natarajan, S., Raman, S., Priester, AM., et al.[2018]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Reliable Visualization of the Treatment Effect of Transperineal Focal Laser Ablation in Prostate Cancer Patients by Magnetic Resonance Imaging and Contrast-enhanced Ultrasound Imaging. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Laser ablation as focal therapy for prostate cancer. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Transperineal laser ablation (TPLA) with ultrasound/MRI fusion guidance in the treatment of localized radiotherapy-resistant prostate cancer. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Laser combined with TURP in the treatment of localized prostatic cancer. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Focal laser interstitial thermotherapy (LITT) at 980 nm for prostate cancer: treatment feasibility in Dunning R3327-AT2 rat prostate tumour. [2012]

6. England pubmed.ncbi.nlm.nih.gov

Which technology to select for primary focal treatment of prostate cancer?-European Section of Urotechnology (ESUT) position statement. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Functional outcomes and safety of focal therapy for prostate cancer: a systematic review on results and patient-reported outcome measures (PROMs). [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Focal Laser Ablation of Prostate Cancer: Phase I Clinical Trial. [2018]